Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer
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Phase
Phase 1
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
499actual
Sites
18
Countries
United Kingdom, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2019-03-20 | actual | When the study began enrolling |
| Primary completion | 2025-01-13 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2019-03-01 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-30 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Advanced Cancer
- Angiosarcoma
- Colorectal Cancer Without Liver Metastases
- Endometrial Cancer
- Fibrolamellar Carcinoma
- Non-small-cell Lung Cancer
- Ovarian Cancer
- Prostate Cancer
Interventions
- Drug: Botensilimab — also filed as AGEN1181, Anti-CTLA-4
- Drug: Balstilimab — also filed as AGEN2034, Anti-PD-1
Primary outcomes
what the primary-completion date above is the date OFIncidence Of Treatment-emergent Adverse Events (TEAEs)
measured First dose through 90 days following last study dose (up to 2 years)
DLT Of Botensilimab
measured First 28 days of treatment
RP2D Of Botensilimab
measured First dose through 90 days following last study dose
Publications
- PMID 41502912 — linked by the registry
- PMID 39869830 — linked by the registry
- PMID 38871975 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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